The Role of Auditory Feedback in Guiding Upper Extremity Movements

Stroke Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02100306
• Other study ID #: JCH-1234-SF
• Status: Not yet recruiting
• Phase: N/A
• First received: March 14, 2014
• Last updated: March 26, 2014
• Start date: May 2014
• Est. completion date: September 2015

Study information

• Verified date: March 2014
• Source: Sunnybrook Health Sciences Centre
• Contact: Tea Lulic, MSc
• Phone: 416 480-6100
• Email: tlulic[@]sri.utoronto.ca
• Is FDA regulated: No
• Health authority: Canada: Sunnybrook ethics institutional review board
• Study type: Interventional

Clinical Trial Summary

Stroke is one of the leading causes of disability, with an estimated prevalence of 50,000 cases per year in Canada. Less than half of stroke patients regain use of their arm and hand. There is currently no intervention regime that is the gold standard, despite the variety of therapeutic techniques used to treat the upper extremity post-stroke. The use of external feedback to improve motor learning is a technique that has been less studied but shows promise. Therefore, the purpose of this proof of principle study it to test whether different auditory feedback frequencies can facilitate reaching ability in people with stroke. In addition brain scans will be collected that will enable us to determine how stroke severity may impact on one's ability to improve with this technique.

We hypothesize that patients who receive less feedback (50% alternate) will have enhanced learning relative to the patients who receive more feedback (100%).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

Inclusion Criteria:

• Unilateral first time MCA ischemic stroke

• Stroke patients should have some movement of shoulder/elbow (no movement of hand - e.g. hand, fingers - is OK)

• > 2 months post

• between 30-85 years

Exclusion Criteria:

• prior stroke

• severe comprehension (or cognitive) deficit that compromises informed consent or understanding of instructions

• contraindications to MRI (e.g. claustrophobia, metal implants)

• neurodegenerative or psychiatric disease

• apraxia

• auditory deficits that would impair testing

• prior musculoskeletal injury to back or upper extremity (including shoulder subluxation from stroke)

• skin conditions that would preclude taping of goniometers

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Auditory Feedback 100%
Patients will receive constant auditory feedback across training trials.
• Auditory Feedback 50% alternate
Patients will receive alternating auditory feedback (1 trial auditory feedback; 1 trial no auditory feedback) across trials

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in movement error from baseline		participants will be followed for the duration of the study, an expected 3 hours per day for 2 weeks (5 days per week/10 days total)	No
Secondary	Change in range of motion		participants will be followed for the duration of the study, an expected 3 hours per day for 2 weeks (5 days per week/10 days total)	No
Secondary	Change in movement duration		participants will be followed for the duration of the study, an expected 3 hours per day for 2 weeks (5 days per week/10 days total)	No

External Links

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